Class II medical device application requirements

With the development of the new crown epidemic, the demand for all kinds of medical products increases. In order to ensure the quality of listed products, the State Food and Drug Administration to strengthen supervision, the operation of medical devices to increase the supervision and control efforts, in the continuous sampling and routine inspections, a lot of non-business qualifications, quality problems of the enterprise, have been ordered to stop business, or even revoke the relevant qualifications. This shows the importance of complying with the business qualification for enterprises.

Medical device license a **** divided into three categories, then the second class of medical devices how to deal with it?

First of all, Class II medical devices refers to the risk of moderate, need to strictly control the management to ensure its safety and effectiveness of medical devices,common daily life of Class II devices are: X-ray film machine, ultrasound, microscope, biochemistry, thermometers, sphygmomanometers, cardiology diagnostic equipment, Medical cotton wool, medical gauze, medical masks, medical protective clothing.

The second class of medical devices products and production activities by the provincial food and drug regulatory departments to implement licensing, respectively, issued by the "Medical Device Registration Certificate" and "Medical Device Manufacturing License. Business activities by the municipal food and drug regulatory departments to implement record management.

For the second class of medical devices required information:

1, the company's business license, organization code certificate copy and company seal;

2, a copy of the legal person ID card and a copy of the diploma;

3, the person in charge of the company's ID card and a copy of the certificate of graduation (legal person and the person in charge of the person can be the same);

4, the person in charge of the company and the person in charge of the company's ID card and a copy of the diploma. );

4, quality management personnel 1: ID card, diploma (medical equipment, biomedical engineering, mechanical, electronic, computer specialized college degree or above) copy;

5, after-sales personnel 1: ID card, diploma (medical equipment, biomedical engineering, mechanical, electronic, computer specialized secondary school degree or above), a copy of;

6, the office of the Real estate license, lease contract, a copy of the landlord's identity card, warehouse real estate license, lease contract, a copy of the landlord's identity card;

7, the medical equipment to be operated by the registration certificate and registration form stamped with the manufacturer's official seal or the seal of the intermediary (used to look at the scene);